- Reading
- Mindfulness Practices
- Yoga
- I enjoy cooking for friends and family gatherings
Preetha R (PMP)®
Plainsboro,NJ
Summary
Experienced(16 years of industrial experience) regulatory affairs professional skilled in navigating complex regulatory landscapes and ensuring compliance. Proven track record of driving successful submissions and approvals for critical projects. Expertise in fostering collaborative team environments and adapting to evolving regulatory requirements. Recognized for delivering reliable results and maintaining high standards throughout the process.
Overview
17
17
years of professional experience
1
1
Certification
Work History
Sr. Regulatory Affairs Specialist
ANI Pharmaceuticals Inc.
04.2021 - Current
- Authored Original ANDA dossiers for solid oral dosages, topicals, transdermal and liquid drug products for USFDA authority of health.
- Peer reviewer of the regulatory submissions for its accuracy and comprehensiveness.
- Hands on experience in post approval submissions by interpreting the type of change (major, minor and annual reportable)
- Worked on Structured Product Label (SPL) for the allotted projects.
- Evaluated changes pertaining to drug product, assessed the degree of a change to devise a regulatory strategy for a submission to USFDA.
- Hands on experience in handling eCTD compilation software (Pharmaready)
- Developed or tracked quality metrics.
- Championed a culture of continuous improvement within the regulatory department, fostering an environment of collaboration and open communication.
- Mentored junior regulatory staff, fostering professional growth and sharing industry knowledge to enhance overall team performance.
- Streamlined regulatory submissions by developing efficient processes and documentation templates.
Deputy Manager-Regulatory Affairs
Pfizer Healthcare India Pvt Ltd
12.2017 - 03.2021
- Responsible for handling Legal Entity Change (LEC) variation for all registered products under Pfizer Brand product portfolio for markets across the globe
- Preparation of impacted CMC dossier sections in collaboration with Global Regulatory Strategist (GRS) and handing off the submission package
- Managing the day to day work activities associated with assigned LEC variations within agreed upon timelines of the executives’ and self
- Responsible for keeping abreast of the project updates concerning the executives’ allotted projects
- Evaluated change controls for completeness, accuracy and required supporting documents
- Initiated change controls when needed
- Hands on experience on the Global Document System tools facilitating the submission packages.
- Developed strong relationships with stakeholders to facilitate smooth communication and project completion.
- Liaised with team members, stakeholders and vendors to coordinate activities, provisioning, environment setup, risk mitigation and follow-up.
- Improved team efficiency by streamlining processes and implementing innovative management strategies.
- Identified areas for improvement within the department, implementing strategic initiatives to address gaps in performance or resources.
- Was provided an esteemed opportunity to undergo a Leadership Development Program conducted by the organization for being a potential budding leader in the organization.
Manager-Regulatory Affairs
Par Formulations Pvt Ltd
11.2014 - 10.2017
- Preparation, Review and Submission of ANDAs in eCTD format (For Oral Dosage Forms) for regulated market- USFDA
- Deriving appropriate regulatory strategy in correlation to the regulatory guidances enhancing speedy approval of products and minimizing the risk rejection of application
- Handling of post approval changes- Prior Approval Supplement, CBE-30, CBE-0
- Preparation of annual reports
- Adequate and accurate responding to the Agency deficiencies- Complete Response Letter, Information Request, Easily Correctable Deficiency, Bioequivalence Deficiency
- Review of raw material, packaging material, finished product specifications and test procedure
- Review and approval of batch records and change control Review of labels and pack inserts
- Review of all regulatory agency compliance materials to guarantee accuracy, timelines, comprehensiveness, and obedience with regulatory standards
- Up to date knowledge on relevant regulatory guidance
- Enhanced interaction with R&D, Manufacturing, Quality, Supply Chain Management and Planning.
Project Manager
Par Formulations Pvt Ltd
11.2011 - 11.2014
- Periodic updates of a product to the management, from the initiation of a research batch to the ANDA submission.
- Coordinated with the internal departments to track down the developments of a product.
- Ensured the availability of required quantity of API/excipients/packing materials for the products in pipeline, R & D, commercial and tech transfer.
- Coordinated and followed up with ARD department for method development and validation of API and the finished product and update the status to the formulation development team.
- Prepared project status report in coordination with the respective departments.
- Identified the bottle neck/challenges involved during a batch development and rectifying it by coordinating with the concerned department and the management to resolve it.
- Shipment of the investigational and the reference products to the CRO for a Bioavailability/Bioequivalence studies.
- Monitored the BA/BE studies at the site on case to case basis.
- Ensured periodic follow ups with the CRO(s) to obtain study activity updates.
Sr. Project Coordinator
Micro Therapeutic Research Labs Private Ltd.
05.2008 - 11.2011
- Successfully handled BA/BE projects individually for both domestic and international clients in the Clinical Research Industry
- Handled non clinical and clinical trial projects for domestic and international clients
- Planning and Scheduling of projects
- Sourcing of new clients/ projects based on the targets
- Updating the management periodically pertaining to the bio study stage by stage activities
- Coordinating with the internal departments for smooth completion of a study
- Conventions of frequent department meetings to identify the challenges faced during the project and resolve it
- Maintenance of the project trackers
- Exploring the project feasibility
- Sponsor Query management
- Project time management
- Preparation of project progress & review reports
- Timely updates of project status to the clients
- Project risk management
- Handling of client complaints
- Preparation of project cost
- Preparation of Standard Operating Procedures (SOP)
- Root cause analysis for project delays
- Handled several BENOC, T License applications to CDSCO on behalf of sponsors
Education
Master Degree (M.Sc) - Applied Microbiology
Justice Basheer Ahmed Sayeed College for Women
01.2007
Bachelors Degree (B.Sc.) - Applied Microbiology
Justice Basheer Ahmed Sayeed College for Women
01.2005
Skills
Continuous Improvement
Regulatory Strategy
Time Management
Leadership skills
Effective Communication
Task Prioritization
Written Communication
Conflict Resolution
Personal Information
- Father's Name: Mr. P. Rajamurthy
- Husband's Name: Mr. S. Ganapathy Narayanan
- Date of Birth: 12/23/84
- Nationality: Indian
- Marital Status: Married
Certification
Project Management Professional (PMP), Project Management Institute
Trainings
- Participated in CMC workshop by Rajashri Survase Ojha (Raaj GPRAC).
- Participated in one day Workshop on ICH-GCP for BA/BE studies, conducted by Arkus Clinical Trials Support Solutions.
- Participated in one day Workshop on Business Etiquettes, conducted by Madras Management Association, Chennai.
- Participated in one day Workshop on Corporate Strategy, Mindspower Innovation, conducted by Dr. Rekha Shetty, Managing Director- Farstar Distribution Network.
Interests
Languages
English
Full Professional
Hindi
Full Professional
Tamil
Native or Bilingual
Timeline
Sr. Regulatory Affairs Specialist
ANI Pharmaceuticals Inc.
04.2021 - Current
Deputy Manager-Regulatory Affairs
Pfizer Healthcare India Pvt Ltd
12.2017 - 03.2021
Manager-Regulatory Affairs
Par Formulations Pvt Ltd
11.2014 - 10.2017
Project Manager
Par Formulations Pvt Ltd
11.2011 - 11.2014
Sr. Project Coordinator
Micro Therapeutic Research Labs Private Ltd.
05.2008 - 11.2011
Bachelors Degree (B.Sc.) - Applied Microbiology
Justice Basheer Ahmed Sayeed College for Women
Master Degree (M.Sc) - Applied Microbiology
Justice Basheer Ahmed Sayeed College for Women
Similar Profiles
Joshua HaatajaJoshua Haataja
IT Summer Student at ANI PharmaceuticalsIT Summer Student at ANI Pharmaceuticals
HOLLY ZICKLERHOLLY ZICKLER
US Vice President, Sales and Training at ANI PHARMACEUTICALSUS Vice President, Sales and Training at ANI PHARMACEUTICALS
Erika LoughreyErika Loughrey
Packaging Operator at ANI PharmaceuticalsPackaging Operator at ANI Pharmaceuticals
Ella WelchElla Welch
Girl Scout Volunteer at Robbinsville Girl Scout Troop 71146Girl Scout Volunteer at Robbinsville Girl Scout Troop 71146
Karthik RamanKarthik Raman
Senior Data Scientist at DLLSenior Data Scientist at DLL